Microsurgical Resection of Intramedullary Spinal Cord Metastases
NCT ID: NCT06042946
Last Updated: 2024-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
60 participants
OBSERVATIONAL
2023-09-01
2025-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The hypothesis is that the surgical treatment of selected ISCM patients does not lead to persistent morbidity and does not increase mortality, compared to patients that are treated non-operatively.
Secondary objectives are to assess pre- to postoperative neurological deficits, ambulatory status, and overall survival of surgically treated ISCM patients.
The investigators intend to include a control cohort of patients with ISCM from participating centers, who underwent non-surgical oncological treatment (radiotherapy with or without chemotherapy). This control cohort of patients will be used to match patients with and without surgical treatment.
Primary endpoint (analysed in surgically treated ISCM patients):
Functional outcome at 90 days after treatment initiation, measured by the modified McCormick Scale. This is a score for grading of neurological function in spinal cord conditions.
The McCormick scale ranges from Grade I (neurologically intact) to grade V (paraplegic or quadriplegic). The McCormick scale is suitable for our retrospective study because of its good reproducibility and comparability.
Secondary endpoints (analysed in surgically treated ISCM patients and analysed in matched patients with and without surgical treatment):
* Functional outcome by the McCormick scale and the modified Japanese Orthopaedic Association scale (mJOA) at 6 and 12 months. This is a score evaluating motor function of upper and lower extremities, sensory function of upper extremities and sphincter function / voidance. The mJOA ranges from 0 - 18 points, with higher score values representing better functional outcome. The minimum clinically important difference of the mJOA is 1-2 points, and scores lower than 14 indicate moderate myelopathy, scores lower than 11 indicate severe myelopathy.
* Ambulatory status and continence at 90 days, 6 \& 12 months (determined by mJOA subscores)
* Neurological outcome, measured by American Spinal Cord Injury Association (ASIA)
* Impairment Scale at 90 days, 6 and 12 months
* Rate \& type of complications at 90 days after treatment according to The Novel Therapy
* Disability-Neurology Grade (TDN grade)16
* Overall survival (in days)
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Registry-Based Cohort Study on the Clinical Outcomes of Spinal Cord Glioma Resection Via the Dorsolateral Sulcus Approach
NCT07066475
nTMS in Planning Stereotactic Radiosurgery in Patients With Brain Metastases in the Motor Cortex
NCT04062305
Multicenter Retrospective Study on Patients Treated with Stereotactic Radiosurgery/Radiotherapy for Single Brain Lesions: Evaluation of Treatment Efficacy and Safety, Also Through Radiomic Analysis Methods.
NCT06869460
Pre-operative Stereotactic Radiosurgery Followed by Resection for Brain Metastases
NCT02514915
Study of Metabolic, Transcriptomic and Proteomic Characteristics in Relapsed Glioblastoma
NCT06430424
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
iscm_resection
-Adult patients admitted to one of the participating centres and treated for ISCM between 2017 and 2023 by resection of the ISCM with or without adjuvant radiotherapy
Microsurgical resection of ISCM
Microsurgical resection of ISCM defines the surgical removal of cancerous tumors that have spread to the spinal cord, using advanced microsurgical techniques and equipment like ultrasound, neuromonitoring, ultrasonic aspirator to prevent damage to the spinal cord.
iscm_radiotherapy
-Adult patients admitted to one of the participating centres and treated for ISCM between 2017 and 2023 by radiotherapy without resection of the ISCM
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Microsurgical resection of ISCM
Microsurgical resection of ISCM defines the surgical removal of cancerous tumors that have spread to the spinal cord, using advanced microsurgical techniques and equipment like ultrasound, neuromonitoring, ultrasonic aspirator to prevent damage to the spinal cord.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Available documentation of admission and postoperative status
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Zürich
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER
University Hospital, Geneva
OTHER
Kantonsspital Aarau
OTHER
Kantonsspital Winterthur KSW
OTHER
Luzerner Kantonsspital
OTHER
Klinikum rechts der Isar Technische Universität München
UNKNOWN
University Hospital Muenster
OTHER
University of Toronto
OTHER
Stanford University
OTHER
Cantonal Hospital of St. Gallen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Felix C. Stengel, MD
Junior Attending Neurosurgeon
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Martin N. Stienen, PD, MD
Role: PRINCIPAL_INVESTIGATOR
Cantonal Hospital St. Gallen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cantonal Hospital St. Gallen, Neurosurgery
Sankt Gallen, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-00292
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.